Package Insert: Information for the Patient

Selincro 18 mg Film-Coated Tablets

nalmefene

Read this package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Selincro contains the active ingredient nalmefene.

Selincro is used to reduce alcohol consumption in adult patients with alcohol dependence who still have a high level of alcohol consumption 2 weeks after their first consultation with their doctor.

Alcohol dependence occurs when a person has a physical or psychological dependence on alcohol consumption.

A high level of alcohol consumption is defined as the consumption of more than 60 g of pure alcohol per day in men and more than 40 g of pure alcohol per day in women. For example, a bottle of wine (750 ml; 12% ABV) contains approximately 70 g of alcohol and a bottle of beer (330 ml; 5% ABV) contains approximately 13 g of alcohol.

Your doctor has prescribed Selincro because you have not been able to reduce your alcohol consumption on your own. Your doctor will give you advice to help you complete the treatment and, thereby, help you reduce your alcohol consumption.

Selincro works by acting on the brain processes responsible for your desire to continue consuming alcohol.

A high level of alcohol consumption is associated with a higher risk of health and social problems.

Selincro may help you reduce your alcohol consumption, and maintain the reduced level of alcohol consumption.

Do not take Selincro:

• If you are allergic to nalmefene or any of the other components of this medication (listed in section 6).
• If you are taking medications that contain opioids, for example, methadone, buprenorphine, or analgesics (such as morphine, oxycodone, or other opioids).
• If you have or have had a recent history of opioid dependence, as you may experience acute opioid withdrawal symptoms (such as nausea, vomiting, tremors, sweating, and anxiety).
• If you are experiencing or suspect that you are experiencing opioid withdrawal symptoms.
• In case of liver or kidney insufficiency (poor liver or kidney function).
• If you are experiencing or have recently experienced several symptoms of alcohol withdrawal (such as seeing, hearing, or feeling things that do not exist, convulsions, and tremors).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Selincro. Inform your doctor about any other illness you may have, such as depression, seizures, liver or kidney disease.

If you and your doctor have decided that your immediate goal is abstinence (not drinking any alcohol), do not take Selincro as it is indicated for reducing alcohol consumption.

If you require urgent medical attention, inform your doctor that you are taking Selincro. The use of Selincro may influence the choice of emergency treatment.

If you are scheduled for surgery, consult your doctor at least 1 week before the procedure. You may need to temporarily interrupt treatment with Selincro.

If you feel strange about yourself, see or hear things that do not exist, and this persists for several days, discontinue administration of Selincro and consult your doctor.

The increased risk of suicide in individuals with excessive alcohol consumption or substance abuse, with or without depression, is not reduced by taking nalmefene.

If you are 65 years of age or older, consult your doctor or pharmacist before starting to take Selincro.

Children and adolescents

Selincro should not be used in children or adolescents under 18 years of age as Selincro has not been evaluated in this age group.

Taking Selincro with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Caution should be exercised when taking medications such as diclofenac (anti-inflammatory medication used to treat, for example, muscle pain), fluconazole (medication used to treat diseases caused by certain types of fungi), omeprazole (agent used to block stomach acid production), or rifampicin (antibiotic used to treat diseases caused by certain types of bacteria) with Selincro.

If you are taking medications that contain opioids, the effect may be reduced or may not have any effect if taken with Selincro. Examples of such medications include certain cough and cold preparations, certain medications for diarrhea, and potent analgesics.

Taking Selincro with food and alcohol

Selincro does not prevent the effects of alcohol intoxication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of using Selincro during pregnancy and breastfeeding is unknown.

If you are pregnant, it is not recommended to take Selincro.

If you are breastfeeding, you and your doctor should decide whether to interrupt breastfeeding or interrupt treatment with Selincro after considering the benefits of breastfeeding for the child and the benefits of treatment for you.

Driving and operating machinery

You may experience side effects such as attention disturbances, visual disturbances, abnormal sensations, nausea, dizziness, somnolence, insomnia, and headache at the beginning of treatment with Selincro. Most of these reactions were mild or moderate, occurred at the beginning of treatment, and lasted from a few hours to a few days. These side effects may affect your ability to drive or perform any activity that requires alertness, including operating machinery.

Selincro contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage

• The recommended dose is one tablet per day when you perceive a risk of alcohol consumption.
• The maximum dose is one tablet per day.

How and When to Take It

• Selincro is for oral use.
• Take the tablet 1-2 hours before alcohol consumption.

• Swallow the tablet whole. Do not break or crush it because Selincro may cause skin sensitization when it comes into direct contact with the skin.
• You can take Selincro with or without food.
• You may be able to reduce your alcohol consumption during the first month after starting treatment with Selincro.
• Your doctor will monitor you regularly, for example, monthly from the start of treatment with Selincro; the actual frequency will depend on your progress. You and your doctor will decide how to continue.

If You Take More Selincro Than You Should

If you think you have taken more Selincro tablets than you should, inform your doctor or pharmacist.

If You Forget to Take Selincro

If you have started consuming alcohol without taking Selincro, take a tablet as soon as possible.

If You Interrupt Treatment with Selincro

When you stop treatment with Selincro, you may be less sensitive to the effects of medications that contain opioids for a few days.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Selincro can cause side effects, although not everyone will experience them.

Side effects related to seeing, hearing, or feeling things that are not really there or feeling strange about oneself are rare (can affect up to 1 in 100 people). If you experience any of these side effects, consult your doctor.

The side effects reported with Selincro were mainly of mild or moderate intensity, occurred at the start of treatment, and lasted from a few hours to a few days.

If you continue treatment with Selincro, or resume it after a break, it is likely that you will not experience side effects.

In some cases, it may be difficult to distinguish between side effects and symptoms you may experience when reducing alcohol consumption.

With Selincro, the following side effects have been observed:

Very common (can affect more than 1 in 10 people):

- sensation of dizziness

- dizziness

- inability to sleep

- headache

Common (can affect up to 1 in 10 people):

- loss of appetite

- difficulty sleeping, confusion, restlessness, reduced libido

- drowsiness, muscle twitching, sensation of being less alert, unusual sensation in the skin like tingling, reduced sense of touch

- rapid heartbeat, sensation of rapid, strong, or irregular heartbeat

- vomiting, dry mouth, diarrhea

- excessive sweating

- muscle spasms

- sensation of exhaustion, weakness, discomfort, or restlessness, feeling of strangeness

- weight loss

Other side effects of unknown frequency (frequency cannot be estimated from available data):

- visual disturbance (mainly transient)

- inflammation of the face, lips, tongue, or throat

- urticaria

- itching

- rash

- skin redness

- muscle pain

- prolonged erection (priapism)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.

• Do not use this medication after the expiration date that appears on the blister pack and the box, after EXP or CAD. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.
• Do not use this medication if you observe any visible signs of deterioration in the tablets, such as tablets that are cracked or broken.
• Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Selincro

• Each film-coated tablet contains 18.06 mg of nalmefene (as dihydrochloride dihydrate).
• The other components are:

Tablet core: microcrystalline cellulose, anhydrous lactose, crospovidone (type A), magnesium stearate.

The film coating contains: hypromellose, macrogol 400, titanium dioxide (E171).

Appearance of the product and contents of the packaging

Selincro is a white, oval, biconvex film-coated tablet, 6.0 × 8.75 mm in size.

The tablet is engraved with “S” on one face.

Selincro is available in blister packs of 7, 14, 28, 42, 49, or 98 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

H. Lundbeck A/S

Ottiliavej 9

DK-2500 Valby

Denmark

Responsible for Manufacturing

H. Lundbeck A/S

Ottiliavej 9

DK-2500 Valby

Denmark

Elaiapharm

2881, Route des Crêtes

Z.I. Les Bouillides

Sophia Antipolis

06560 Valbonne

France

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.

Last review date of this leaflet: 01/2025